NCT06383182

Brief Summary

Acute ischaemic stroke (AIS) results in high rates of neurological morbidity and mortality, especially in patients with large vessel occlusion (LVO). Endovascular therapy (EVT) has been approved as the most effective treatment for patients with LVO , but about half patients undergoing EVT did not achieve good outcome. The mechanisms of poor prognosis are complex. How to accurately identify serological biomarkers related to patients' clinical prognosis is an important research topic nowadays.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Jul 2024Dec 2026

First Submitted

Initial submission to the registry

April 17, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

April 17, 2024

Last Update Submit

August 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dynamic changes in serum biomarkers after endovascular treatment

    These biomarkers will be identified based on proteomic methods

    from the baseline to immediately, 30 minutes, 6 hours, and 24 hours after endovascular treatment

Secondary Outcomes (7)

  • favourable functional outcome, defined as modified Rankin Scale (mRS) 0-2

    90±7 days

  • excellent functional outcome, defined as modified Rankin Scale (mRS) 0-1

    90±7 days

  • distribution of modified Rankin Scale (mRS) score

    90±7 days

  • early neurological improvement, defined as 4 or more decrease in National Institute of Health stroke scale (NIHSS)

    24±8 hours

  • changes in National Institute of Health stroke scale (NIHSS)

    24±8 hours

  • +2 more secondary outcomes

Other Outcomes (3)

  • the association between cerebral circulation time (CCT) and clinical outcomes

    24±8 hours, 10±2 days, 90±7 days

  • the association between serum biomarkers and clinical outcomes

    24±8 hours, 10±2 days, 90±7 days

  • the association between serum biomarkers and status of vessel recanalization

    24±8 hours, 10±2 days, 90±7 days

Interventions

all patients with anterior circulation large vessel occlusion will receive endovascular treatment.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute anterior circulation large vessel occlusion within 24 hours of onset who will receive endovascular treatment

You may qualify if:

  • Age: 18-80 years;
  • Patients with acute anterior circulation large vessel occlusion within 24 hours of onset who will receive endovascular treatment;
  • Pre-stroke mRS: 0-1;
  • Baseline NIHSS: ≥6;
  • Signed informed consent.

You may not qualify if:

  • The presence of contraindications to internal jugular vein cannulation;
  • Receiving intravenous thrombolysis;
  • Haemorrhagic stroke (cerebral haemorrhage or subarachnoid haemorrhage);
  • Coagulation disorders, systemic bleeding tendency, thrombocytopenia (\<100×109/L);
  • Severe cardiac, hepatic or renal insufficiency (ALT or AST elevated more than 2 times the upper limit of normal value, or serum creatinine elevated more than 1.5 times the upper limit of normal value or in need of dialysis) or other serious medical diseases;
  • Severe uncontrolled hypertension (systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg);
  • Pregnant or lactating women;
  • Other conditions who are not suitable for this trial by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, 110840, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
90 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 17, 2024

First Posted

April 25, 2024

Study Start

July 2, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations